NICE updated infection control guidelines

29th March 2012

An updated guideline on the prevention and control of healthcare-associated infections in primary and community care has been published by the UK National Institute for Health and Clinical Excellence (NICE). The updated guideline takes into account new evidence that has been published since NICE's original guideline in 2003.

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MHRA alert for co-codamol 8/500 tablets

28th March 2012

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has issued a patient level recall for a batch of co-codamol 8/500 tablets (Wockhardt UK Ltd; batch code LL11701; expiry September 2014; first distributed December 2011). Rogue higher strength co-codamol 30/500 tablets have been found in this batch.

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NPSA RRR: Harm from flushing of nasogastric tubes before confirmation of placement

27th March 2012

The UK National Patient Safety Agency (NPSA) has issued a Rapid Response Repost (RRR) following two patient deaths since 10 March 2011 where staff had flushed nasogastric tubes with water before initial placement had been confirmed. 

Misplaced nasogastric tubes leading to death or severe harm are ‘never events’. The patient safety alert Reducing the harm caused by misplaced nasogastric feeding tubes in adults, children and infants was issued by the NPSA on 10 March 2011 with an action complete date of 12 September 2011. Alongside other actions, the alert requires all organisations to ensure that ‘Nasogastric tubes are not flushed, nor any liquid/feed introduced through the tube following initial placement, until the tube tip is confirmed by pH testing or x-ray to be in the stomach.’ 

Confusion appears to have arisen over nasogastric tubes with water-activated lubricants. The above guidance is applicable for all nasogastric tubes including those with water-activated lubricants. The lubricant is not needed for placement, only to aid removal of the guidewire/ stylet from the tube after gastric placement has been confirmed. 

All organisations in the NHS and independent sector where nasogastric feeding tubes are placed and used for feeding patients should ensure that the following implemented by 21-09-2012:

1.     Assign a named clinical lead to coordinate implementation of the actions in this RRR with any actions outstanding from the earlier Alert 

2.     Remind all staff responsible for checking initial placement of nasogastric tubes (including staff who support parents/carers who check initial placement of nasogastric tubes):

a.    NOTHING should be introduced down the tube before gastric placement has been confirmed

b.    DO NOT FLUSH the tube before gastric placement has been confirmed

c.     Internal guidewires/ stylets should NOT be lubricated before gastric placement has been confirmed

3.    This reminder should be given through:

a.    Distributing this RRR to all relevant staff

b.    Providing warning notices and/ or overwraps with warning labels on all current and future stock of nasogastric tubes, until these are provided as standard by manufacturers

c.     Reviewing and, if necessary, amending all local policy, protocol and training materials.

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Capsaicin patch license extension application withdrawn

21st March 2012

Astellas Pharma has withdrawn its application to the European Medicines Agency (EMA) for a license extension for Qutenza^® (capsaicin 8% transdermal patch). The application was to extend the marketing authorization for Qutenza^® to all adult patients with exclusion of patients with pain caused by diabetes. 

The withdrawal was based on the Committee for Medicinal Products for Human Use (CHMP)'s view that the data provided would not allow the committee to conclude on a positive benefit-risk balance.

Qutenza^® continues to be authorized for the treatment of peripheral neuropathic pain (PNP) in non-diabetic adults either alone or in combination with other medicinal products for pain.

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Wir freuen uns, Ihnen den ersten APM Newsletter vorstellen zu dürfen

20th March 2012

We are happy to present the first APM Newsletter for German-speaking users of www.palliativedrugs.com!
Wir freuen uns, Ihnen den ersten APM Newsletter vorstellen zu dürfen. Der Newsletter wird alle zwei Monate erscheinen und soll Sie über aktuelle Themen im Bereich der palliativmedizinischen Arzneimitteltherapie informieren. Er ist Teil des Angebotes, das Ihnen kostenfrei unter www.arzneimittel-palliativ.de zur Verfügung steht. Sie können den aktuellen Newsletter auf der Website palliativedrugs.com im Bereich "News" herunterladen. Über aktuelle Ausgaben des Newsletters wird Sie das Bulletin Board informieren. Alternativ können Sie sich unter newsletter@arzneimittel-palliativ.de kostenfrei für den Newsletter registrieren.

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Alert update on Prednisolone e/c recalled from Teva

20th March 2012

Following the Medicines and Healthcare products Regulatory Agency (MHRA) recall of prednisolone enteric coated (e/c) blister packs from Teva UK (see our news item 16-12-2011), the recall has been extended to certain batches of prednisolone 2.5mg and 5mg e/c tablets packed in pots. Again, this is due to elevated levels of related substances being detected during stability studies.

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MHRA launches opioid learning module

16th March 2012

A self-directed learning package outlining the key risks and undesirable effects of opioids has been launched by the Medicines and Healthcare products Regulatory Agency (MHRA) for doctors, pharmacists and nurses.

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Tapentadol DTB review

15th March 2012

The Drug and Therapeutics Bulletin (DTB) has featured a review on the evidence for tapentadol (Palexia^®; Grünenthal) for moderate to severe acute pain.

The bulletin highlights some of the limitations of the available evidence as follows (taken directly from source): 

• This evidence base for the treatment of acute pain is limited to comparisons between tapentadol and oxycodone or placebo; other than a single-dose phase II trial, there are no published studies comparing tapentadol with other drugs that might be more relevant in clinical practice, and with which clinicians will be more familiar (e.g. codeine, morphine).

• Non-opioid analgesics were not given before moving on to, or in combination with, the trial drugs (which might be tried in practice).

The review concludes that tapentadol has been shown to have similar efficacy compared to oxycodone although evidence to suggest that it has fewer gastrointestinal undesirable effects compared to oxycodone is limited. "Further studies are required comparing tapentadol in the management of acute pain with morphine or alternative opioids other than oxycodone before it can be recommended for routine use. In view of the trial limitations and lack of comparison with other analgesics, it is difficult to see a place in therapy for tapentadol in the management of moderate to severe acute pain at present."

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Loron (clodronate disodium 520mg tablets) change of licence holder

13th March 2012

Roche Products Ltd has issued a notification of divestment and related new distribution arrangements for Loron (clodronate disodium 520mg tablets).This product is being divested to Riemser Arzneimittel AG and the supplier of Loron to the UK will change to Intrapharm Laboratories from 2nd April 2012. Loron will be available from all mainline wholesalers and Intrapharm’s distributor Movianto UK Ltd. Intrapharm will continue to sell stock in Roche livery until new stock make-up is available. All orders received up until Friday 30th March will be delivered. For more information contact Movianto order processing and customer Service: 01234 248 632, orders.uk@movianto.com, or Roche customer care: 0800 731 5711.

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SMC accepts Bufyl

13th March 2012

The Scottish Medicines Consortium (SMC) has accepted bupivacaine HCL 1mg/mL and 1.25mg/mL plus fentanyl (as citrate) 2microgram/mL solution for infusion (Bufyl^®; Goldshield, Croydon, Surrey) for use within NHS Scotland as epidural analgesia, to relieve pain during labour and to control post-operative pain. It states that for patients in whom the combination of bupivacaine and fentanyl is an appropriate choice of therapy, Bufyl^® provides two fixed-dose, pre-mixed preparations.

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AWMSG issues final appraisal for capsaicin 8% patch

9th March 2012

The All Wales Medicines Strategy Group (AWMSG) does not recommended Capsaicin 8% patch (Qutenza® Astellas Pharma, Staines, Middlesex, UK) as an option, within NHS Wales, for use on its own for the treatment of peripheral neuropathic pain (PNP) in non-diabetic adults.

The Group does recommend capsaicin patch as an option for restricted use within NHS Wales for the treatment of PNP in non-diabetic adults in combination with other medicinal products for pain and in patients who have not received adequate benefit from, or are intolerant to, alternative conventional treatments. Patches should be administered by specialists.

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WHO guidelines for treating persistent pain in children

8th March 2012

The World Health Organization (WHO) has published a package on the pharmacological treatment of persisting pain in children with medical illnesses, which replaces the previous guidelines 'Cancer pain relief and palliative care in children'. The package contains information for:

• physicians and nurses 
• pharmacists 
• policy-makers and medicines regulatory authorities, hospital managers and health insurance managers,

a dosing card, pain scales and a wall chart.

Changes to the guidelines include recommending using analgesic treatments in two steps according to the child’s level of pain severity. Paracetamol and ibuprofen are the medicines of choice in the first step: the treatment of mild pain. In the second step, the treatment of moderate to severe pain, morphine is the medicine of choice. WHO recommends that codeine and tramadol no longer be used for children. Finally, the initial dosages of strong opioids recommended by WHO are lower than those recommended elsewhere.

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DH guidance on clostridium difficile infections

8th March 2012

The UK Department of Health (DH) has issued revised guidance on how to test, report and manage clostridium difficile infections.

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New combined bupivacaine and fentanyl epidural infusion

7th March 2012

A combined bupivacaine and fentanyl solution for epidural infusion has been launched in the UK (Bufyl^®,Goldshield). It is indicated for maintaining analgesia post-operatively and during labour and comes in two strengths bupivacaine 1mg/mL (0.1%) combined with fentanyl 2microgram/mL  and bupivacaine 1.25mg/mL (0.125%) combined with fentanyl 2microgram/mL. The NHS cost of a 250mL or 500mL infusion bag of either strength is approximately £9.

SPC Bufyl 1mg/mL and 2microgram/mL infusion

SPC Bufyl 1.25mg/mL and 2microgram/mL infusion

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NPSA signal on prevention of harm with buccal midazolam

7th March 2012

The UK National Patient Safety Agency (NPSA) has highlighted the potential for errors to occur when administering buccal midazolam, in a signal report.  Signals are notifications of key risks emerging from review of serious incidents reported to the National Reporting and Learning System (NRLS) and shared by the NPSA. Between April 2008 and August 2011, 132 medication incidents were reported; three were associated with severe harm, five with moderate harm and the remainder with no or low harm. NPSA highlight the risk of a dosing error caused by transferring from unlicensed buccal midazolam 10mg/mL to licensed buccal midazolam 5mg/mL (Buccolam^®), which has also been addressed by the MHRA (see our news item 13-10-2011) and the risk of a product with a ‘Luer’ connector being inadvertently administered via the IV route. One manufacturer of an unlicensed buccal midazolam 10mg/mL preparation (Epistatus^®, Special Products) is currently changing their syringes to non-luer tips (see our news item 14-02-2012). NPSA recommend minimizing these risks by:

• using licensed medicines where possible
• developing a Trust policy to cover the use of unlicensed medicines, including midazolam
• developing a written protocol for the use of buccal midazolam, which includes essential information on clinical indication, dose and administration method, and ensuring that this is available in all clinical areas using this medicine
• ensuring that the dose is always prescribed in mg and mL
• ensuring that buccal midazolam is only administered using oral syringes that are not compatible with intravenous or other parenteral devices.

An additional risk with Epistatus^® (Special Products) was highlighted recently due to a change in syringe size supplied with the product and the risk of wrong dose errors (see our news item 14-02-2012). 

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CHMP recommends a marketing authorisation for granisetron patch

6th March 2012

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion, recommending the granting of a marketing authorisation for granisetron 3.1mg/24h transdermal patch (Sancuso) intended for the prevention of nausea and vomiting associated with moderately or highly emetogenic chemotherapy.

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CHMP recommends a marketing authorisation for generic zoledronic acid

6th March 2012

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion, recommending the granting of a marketing authorisation for generic zoledronic acid 4mg/5mL concentrate for solution for infusion intended for the prevention of skeletal related events in adult patients with advanced malignancies involving bone, and the treatment of tumour-induced hypercalcaemia.

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